Class 2 Device Recall Hitachi Proton Beam Therapy

• Date Initiated by Firm: February 06, 2026
• Date Posted: February 20, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1430-2026
• Recall Event ID: 98330
• 510(K)Number: K191801 K201042
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• Product: Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
• Code Information: Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
• FEI Number: 1000162206
• Recalling Firm/ Manufacturer: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha; 44-141-1,W 226; Wakashiba; Kashiwa Japan
• For Additional Information Contact: Yuki Terakado; 408-9866300
• Manufacturer Reason for Recall: Software anomaly in the patient positioning system may result in positional discrepancy.
• FDA Determined Cause: Software design
• Action: Between the dates of February 5-11, 2026, Hitachi, Ltd, issued an "URGENT: MEDICAL DEVICE RECALL" notification dated January 21, 2026, via Service Team Manager to affected consignees. Hitachi is asking consignees to take the following actions: 1. Until the PPS software has been updated with the corrected version, users are instructed to follow the System Operation instruction in the document. 2. Users are also asked to post the document in a prominent space and sign its cover. 3. Complete and return the acknowledgment and receipt form. Action by the firm: Hitachi plans to update the PPS software to a corrected version that prevents the mismatch between the commanded error correction parameter and the internal variable. starting in late March 2026 and the users will be contacted after the update. If you have any questions, please call QA Manager at Tel: (408) 986-6300. Monday through Friday, 8:00 AM to 5:00 PM, Central Time.
• Quantity in Commerce: 1 unit
• Distribution: US distribution to states of: TX, Washington DC
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LHN